At 5 years, COMMENCE results indicate a favourable safety profile and stable haemodynamic performance of a bioprosthetic valve with RESILIA tissue. Ten-year data in an extended follow-up cohort and the RESILIENCE trial with 11-year follow-up are forthcoming.
Lifetime management of aortic stenosis: true potential and limitations of TAVR vs SAVR
Prof. Borger
Aortic Highlights course, 2023
Dr. Buschmann
Dr. Cresce
Aortic Highlights course, 2023
Dr. Winkler
Aortic Highlights course, 2023
Prof. Von Bardeleben
Aortic Highlights course, 2023
Live Case filmed at Hezrklinik Hirslanden, with:
- Prof. Dr. Med. Jürg Grünenfelder
- PD Dr. Med. Patric Biaggi
Prof. Sabine Bleiziffer
MVT Aortic 2022, vol.1
– A comprehensive lecture about the indications, technical aspects, and results of the rare but challenging procedure of TAVI explantation
– When looking at long-term data, acknowledge the high mortality rates and think about which era the original valves were implanted (technology and overall know-how)
– Be sure to totally familiarize yourself with the technology, implantation method, material, and design of the originally implanted valve
Prof. Friedhelm Beyersdorf
MVT Aortic 2022, vol.1
– Guidelines: based on scientific data, not an individual hospital’s, country’s, or region’s practices.
– It’s important to truly understand the recommendations and evidence classifications.
–Pay attention to the details in phrasing.
Historically, survival data on patients with mild-to-moderate aortic stenosis (AS) have been limited. This situation was addressed in 2019, however, when Strange et al. published their analysis of the relationship between AS severity and mortality in a cohort of 241,303 adult patients in an observational registry. The mean age of patients at baseline was 61 years and median follow up was 1,208 days. Mild and moderate AS were found in 6.7% (n=16,129) and 1.4% (n=3,315) of patients, respectively.1
While it has been observed that severe AS is associated with poor survival, this study also suggests poor survival rates in patients with moderate AS. The five-year mortality rate for these patients was 56% (mean gradient 20.0–39.9 mmHg and/or peak velocity 3.0–3.9 m/s and/or aortic valve area greater than 1 cm²).
Mortality rates according to AS severity
The importance of early referral, regular clinical and echocardiographic surveillance and early intervention were emphasised in the recent update to the ESC/EACTS Guidelines for the management of valvular heart disease.2 In addition to recommendations for an active collaboration among Heart Team members and the inclusion of the informed patient’s preferences when determining optimal treatment, specific recommendations relevant to patients with moderate AS include:2
- Regular clinical and echocardiographic surveillance where prognosis of patients with normal-flow,
low-gradient AS and preserved ejection fraction is similar to that of moderate AS - Earlier referral if patient’s symptoms advance or worsen
- Earlier intervention to be considered in asymptomatic patients with:
- severe AS and left ventricular ejection fraction (LVEF) <55% without another cause (IIa)
- severe AS and a sustained fall in blood pressure (>20 mmHg) during exercise testing (IIa)
- LVEF >55% and a normal exercise test if the procedural risk is low and one of the following is present: very severe AS, severe valve calcification plus Vmax progression >0.3 m/s/year, or markedly elevated B-type natriuretic peptide levels without other explanation is present (IIa)2
The ESC/EACTS guidelines also support consideration of earlier intervention in select patients with asymptomatic aortic regurgitation.2
References
1. Strange G, Stewart S, Celermajer D et al. Poor long-term survival in patients with moderate aortic stenosis. JACC. 2019; 74: 1851–63.
2. Vahanian A, Beyersdorf F, Praz F et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2021.
Edwards, Edwards Lifesciences, and the stylized E logo are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
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Dr. Vinod Thourani
Be courageous, be experienced, be ethical … according to the Guidelines!
Prof. Hanneke Takkenberg
Be courageous, be experienced, be ethical … according to the Guidelines!
Prof. Bart Meuris
Be courageous, be experienced, be ethical … according to the Guidelines!
Dr. Alison Duncan
Be courageous, be experienced, be ethical … according to the Guidelines!
The 2021 update of the ESC/EACTS Guidelines for the management of valvular heart disease, recommends treating patients with severe aortic stenosis younger than 75 years and low risk with surgical aortic valve replacement (SAVR), simplifying the initial patient treatment pathway and preferred mode of intervention. The implication is that valve durability is now even more important because of younger patients’ greater longevity.
Edwards Lifesciences has two ongoing trials, COMMENCE and EU Feasibility, that are evaluating the longevity of a bioprosthetic valve with novel RESILIA tissue. Both trials have demonstrated a favourable safety profile and good haemodynamic performance at 5 years, with additional follow-up to be conducted up to 10 years.1,2
The COMMENCE trial
Safety endpoints, probability event-free:
COMMENCE is an FDA pivotal trial designed to evaluate the safety and effectiveness of the INSPIRIS bioprosthetic aortic valve with the novel RESILIA tissue.1 The 5-year data are now available:
· All-cause mortality 89.2%
· Major paravalvular leak 99.5%
· Endocarditis 97.8%
Improved haemodynamic performance from baseline
The absence of structural valve deterioration through 5 years* and the presence of stable gradients, plus freedom from regurgitation support durability over the observational period.
*One case of structural valve deterioration was diagnosed at postoperative Day 1,848.
The RESILIA EU Feasibility study
The RESILIA EU Feasibility study has investigated the safety and performance in aortic valve replacement patients of the bioprosthesis with the novel RESILIA tissue at 5 years.2 Here, we summarise the results at 5 years:
Stable haemodynamic performance:
Mean gradient was 14.8 ± 7.6 mmHg
Average effective orifice area was 1.4 ± 0.5 cm2
Zero structural valve deterioration events and stable transvalvular gradients were observed at 5 years.
At 5-years, results from the EU Feasibility study represent the longest follow-up of aortic valve replacement patients with RESILIA tissue and demonstrate excellent haemodynamic performance and safety outcomes.1
Recommended resources
https://edwardseducation.com/edwardsmasters/the-latest-tissue-valve-technology-responding-to-the-unmet-needs-in-avr/
References
1. Bavaria J, Griffith B, Heimansohn DA et al. Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with a novel tissue bioprosthesis. Presented at the Society of Thoracic Surgeons (STS) Annual Meeting, January 29-31, 2021.
2. Bartus K, Litwinowicz R, Bilewska A et al. Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis. Eur J Cardiothorac Surg 2020; 59: 434–41.
No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).
Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.
Edwards, Edwards Lifesciences, the stylized E logo, COMMENCE, INSPIRIS, INSPIRIS RESILIA, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
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Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
With the publication of the 2021 update to ESC/EACTS guidelines for the management of valvular heart disease, new guidance should be considered when caring for patients with severe aortic stenosis.1
Three key recommendations stand out:
Early intervention is recommended for asymptomatic patients with a LVEF below 55% without another cause
An emphasis on Heart Team collaboration to provide the optimal treatment while informing and involving patients in their decision-making
A clear age delineation that patients younger than 75 years of age with severe aortic stenosis receive SAVR, and patients older receive TAVI
It is established that the durability of modern surgical bioprosthetic valves is over 10 years,2 and in recent years there has been a trend towards a greater use of bioprosthetic valves.3 On the other hand, mechanical valves continue to be associated with bleeding risks because of the need for lifelong anticoagulation therapy, leading to lifestyle changes.4-6
Several large, long-term studies have demonstrated up to 20-year durability for the bioprosthetic Carpentier-Edwards PERIMOUNT
aortic valve.2,7,8
Carpentier-Edwards PERIMOUNT valve
Two ongoing trials, COMMENCE and EU Feasibility, are evaluating the longevity of bioprosthetic aortic valves with novel RESILIA tissue after five-year implantation. Five-year results from these studies have demonstrated a favourable safety profile and good haemodynamic performance.9,10
INSPIRIS RESILIA aortic valve
Another study found that the INSPIRIS RESILIA valve reduced the length of hospital stay compared with mechanical valves (6.6 days versus 10.3 days).11 Selecting the right treatment for the patient requires many considerations, most importantly the desire of the informed patient.
Additionally, the Heart Team needs to consider the age, estimated life expectancy, comorbidities, and anatomical and procedural characteristics of the patient; relative risks and long-term outcomes associated with SAVR or TAVI; prosthetic heart valve durability; feasibility of transfemoral TAVI; and local experience and outcome data to achieve optimal outcomes for patients.1
Recommended resources
References
1. Vahanian A, Beyersdorf F, Praz F et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2021: doi:10.1093/eurheartj/ehab395.
2. Johnston DR, Soltesz EG, Vakil N et al. Long-term durability of bioprosthetic aortic valves: Implications from 12,569 implants. Ann Thorac Surg. 2015; 99: 1239–47
3. Bartus K, Sadowski J, Litwinowicz R et al. Changing trends in aortic valve procedures over the past ten years—from mechanical prosthesis via stented bioprosthesis to TAVI procedures—analysis of 50,846 aortic valve cases based on a Polish National Cardiac Surgery Database. J Thorac Dis. 2019; 11: 2340–9.
4. Head SJ, Çelik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. 2017; 38: 2183–91.
5. Reul RM, Ramchandani MK, Reardon MJ. Transcatheter aortic valve-in-valve procedure in patients with bioprosthetic structural valve deterioration. Methodist DeBakey Cardiovasc J. 2017; 13: 132.
6. Swinkels B, Ten Berg J, Kelder J et al. What can we learn from the past by means of very long-term follow-up after aortic valve replacement? J Clin Med. 2021; 10: 3925.
7. Bourguignon T, Bouquiaux-Stablo A-L, Candolfi P et al.Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position. Ann Thorac Surg. 2015; 99: 831–7.
8. Forcillo J, Pellerin M, Perrault LP et al. Carpentier-Edwards pericardial valve in the aortic position: 25-years experience. Ann Thorac Surg. 2013; 96: 486–93.
9. Bartus K, Litwinowicz R, Bilewska A et al. Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis. Eur J Cardio-Thorac Surg. 2021; 59: 434–41.
10. Bavaria J, Griffith B, Heimansohn DA et al. Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with a novel tissue bioprosthesis. Presented at the Society of Thoracic Surgeons (STS) Annual Meeting 2021.
11. Meuris B. Innovation in anticalcification technology in heart valves leads to lower hospital stay in adults undergoing aortic valve replacement. Oral Presentation at HTAi 2021 virtual congress.
No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).
Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, COMMENCE, INSPIRIS, INSPIRIS RESILIA, PERIMOUNT, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2950 v1.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
Prosthetic valve choice and mode of intervention for aortic valve replacement in younger patients have been controversial because of concerns about long-term durability. The 2021 update to the ESC/EACTS guidelines for the management of valvular heart disease makes recommendations for patients with severe aortic stenosis, based on available evidence and
valve replacement innovation.1
In patients with severe aortic stenosis, age is now a key determining factor in the initial
choice between SAVR or TAVI. This change simplifies the initial patient treatment pathway
and preferred mode of intervention for patients with severe aortic stenosis.
The guidelines emphasise that while the durability of surgical bioprosthetic valves
beyond 10 years is well established, evidence supporting the durability of TAVI valves is
more limited.
As valve durability is a key consideration in younger patients (<75 years) at low surgical risk, SAVR (if feasible) is the preferred treatment option. SAVR is also recommended for patients who are unsuitable for transfemoral TAVI and operable.
The guidelines recommend TAVI for older patients (≥75 years) and those who are inoperable or high risk for surgery (particularly if feasible via the transfemoral approach).
SAVR or TAVI are recommended for remaining patients according to individual
clinical, anatomical and procedural characteristics.
Prosthesis selection: Tissue or mechanical valve?
If the Heart Team and patient agree that SAVR is the way forward, the choice between mechanical and biological valves comes to the fore. Key factors for the Heart Team to consider are:
- The patient’s life expectancy
- Lifestyle and environmental factors
- Bleeding and thromboembolic risk related to anticoagulation
- Potential for surgical or transcatheter reintervention
- Informed patient choice
The evidence continues to support the use of aortic bioprostheses for patients over 65 years of age, but just how durable are bioprostheses?
Latest recommendations are supported by real-world evidence and consistent clinical outcomes
Several large, long-term studies have demonstrated the excellent long-term durability of the Carpentier-Edwards PERIMOUNT aortic valve.2–9
Carpentier-Edwards PERIMOUNT valve
Overall expected valve durability of the PERIMOUNT aortic valve is 19.7 years.2-4
- Broken down by age, durability was
- 17.6 years for patients aged ≤60 years
- 19 years for patients aged 50–65 years
- 22.1 years for patients aged 60–70 years
- Twenty-year probability of explant due to SVD across all age groups is 5.4%7
- Younger age at implantation is associated with a higher risk of structural valve deterioration,2,6-9 but durability is good even in these younger patients2,6-9
Recommended resources
References
1. Vahanian A, Beyersdorf F, Praz F et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2021:
2. Bourguignon T, Bouquiaux-Stablo A-L, Candolfi P et al. Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position. Ann Thorac Surg. 2015; 99: 831–7.
3. Bourguignon T, El Khoury R, Candolfi P et al. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged 60 or younger. Ann Thorac Surg. 2015; 100: 853–9.
4. Bourguignon T, Lhommet P, El Khoury R et al. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged 50–65 years. Eur J Cardio-Thorac Surg. 2016; 49: 1462–8.
5. Forcillo J, El Hamamsy I, Stevens LM et al. The Perimount valve in the aortic position: Twenty-year experience with patients under 60 years old. Ann Thorac Surg. 2014; 97: 1526–32.
6. Forcillo J, Pellerin M, Perrault LP et al. Carpentier-Edwards pericardial valve in the aortic position: 25-years experience. Ann Thorac Surg. 2013; 96: 486–93.
7. Johnston DR, Soltesz EG, Vakil N et al. Long-term durability of bioprosthetic aortic valves: Implications from 12,569 implants. Ann Thorac Surg. 2015; 99: 1239–47.
8. McClure RS, Narayanasamy N, Wiegerinck E et al. Late outcomes for aortic valve replacement with the Carpentier-Edwards pericardial bioprosthesis: up to 17-year follow-up in 1,000 patients. Ann Thorac Surg. 2010; 89: 1410–6.
9. Minakata K, Tanaka S, Okawa Y et al. Long-term outcome of the Carpentier-Edwards Pericardial valve in the aortic position in Japanese Patients. Circ J. 2014; 78: 882–9.
For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).
Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, INSPIRIS, INSPIRIS RESILIA, Magna, Magna Ease, PERI, PERIMOUNT, RESILIA and SAPIEN are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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A key focus of the new ESC/EACTS guidelines is the instrumental role of the Heart Team in decisions concerning intervention and treatment, and the importance of collaborative decision making, taking both the Heart Team’s expert guidance and the wishes of the patient into consideration.
Key points include:
Heart Team recommendations must be discussed with patient and family to allow informed treatment choice
Heart Valve Centres are a key component of the Heart Team approach
Early Heart Team referral encouraged if patient’s symptoms develop/worsen before next planned visit
All patients with severe aortic stenosis must be referred through the Heart Team
Joint decision making gets the right treatment to each patient
ESC/EACTS guidelines now recommend that an active and collaborative Heart Team make decisions about intervention and treatment.
Your expertise means you are best placed to recommend the optimal valve procedure for the patient, in collaboration with the other specialists and dedicated personnel of the Heart Team.
Class I recommendations for a collaborative Heart Team approach
The choice between a surgical or transcatheter approach will depend on evaluation of the clinical, anatomical and procedural factors by the Heart Team, considering the risks and benefits for each individual patient.
Interventions should be performed in Heart Valve Centres, using a structured and collaborative Heart Team approach.
All procedural decisions should be patient-centred, giving consideration to age, operative risk, the patient’s life expectancy, lifestyle and environmental factors, their potential for reintervention and any co-morbidities. The final recommendation should also consider the desires of the patient. Ensure you meet your patients’ high expectations by offering them the best valve technologies. Early referral is encouraged if a patient’s symptoms develop/worsen before the next planned visit.
All procedural decisions should be patient-centred, giving consideration to age, operative risk, the patient’s life expectancy, lifestyle and environmental factors, their potential for reintervention and any co-morbidities. The final recommendation should also consider the desires of the patient. Ensure you meet your patients’ high expectations by offering them the best valve technologies. Early referral is encouraged if a patient’s symptoms develop/worsen before the next planned visit.
Interested in finding out more
The upcoming EACTS Annual Meeting has several sessions relevant for these changes:
- Meet the people behind the guidelines in 2021 EACTS/ESC Guidelines for the management of valvular heart disease: Meet the task force members in room 111, at 12:30 on Saturday 16 October
- Join Drs Bonaros and Bourguignon for Problems and concerns related to the choice of an optimal aortic valve substitute in room 111 on Thursday 14 October at 14:15
- Challenging decisions and long-term outcomes in tricuspid and mitral disease with Professor Folliguet is one to attend in room 115 at 16:15 on Friday 15 October
Check out the Edwards congress hub for more information about their upcoming symposia, or meet them onsite at the booth.
You can also read more practical information about the ESC/EACTS guidelines
- Check out Professor Michael Borger’s recent presentation on what’s missing from the new ESC/EACTS guidelines
Edwards, Edwards Lifesciences, and the stylized E logo are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
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The highly anticipated 2021 European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) guidelines for the management of valvular heart disease have finally landed.
We are excited to bring you a summary of the main updates, plus the new materials coming soon to support you and your teams in understanding and implementing the changes.
Key points include:
Treatment recommendations for all patients with severe aortic stenosis to be made by the Heart Team
Intervention options for patients with asymptomatic aortic stenosis
Bioprosthetic valves now recommended for those with life expectancy shorter than valve durability
Intervention recommended for patients with secondary mitral regurgitation, who remain symptomatic despite guideline-directed medical therapy
Use your experience of severe aortic stenosis to ensure the best patient outcomes
The choice between surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) must be made following evaluation of all factors – clinical, anatomical and procedural – weighing the risks and benefits of each approach for all patients with severe aortic stenosis, and after discussion with the patient.
Treatment options have broadened for patients with asymptomatic aortic stenosis, including those with systolic left ventricular (LV) dysfunction (LV ejection fraction <55%) without another cause.
Enable more of your patients to live the active lifestyle they desire
Bioprosthetic valves now have a Class I recommendation for patients with life expectancy lower than the durability of the valve. Now, more of your patients can live a life free from anticoagulation. In addition, bioprosthetic valves may be considered for patients already on long-term novel oral anticoagulants.
Ensure you meet your patients’ high expectations by offering them the best valve technologies.
Be courageous, be experienced, be ethical… according to the guidelines!
Join us from the comfort of your office for a virtual symposium discussing the changes and what they mean for your practice. Eleven speakers from across Europe will cover the implications for the aortic, mitral and tricuspid valves. Click here for the full programme.
Tuesday 21 September 2021
3.00–7.45 pm CET
REGISTER NOW
Coming soon from Edwards
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reserved. NP–EU-0633 v1.0
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Ai L et al. Innovations. 2017; 12: 338–45. DOI: 10.1097/imi.0000000000000407
Aim
To develop a clinically relevant aortic root model, and then compare the haemodynamic function of the EDWARDS INTUITY valve (a rapid deployment valve) with the Carpentier- Edwards PERIMOUNT Magna Ease valve (a conventional bioprosthetic valve), in vitro.
Background Information
Many trials have shown the short-term safety and efficacy of sutureless rapid deployment aortic valves, but direct comparisons of the haemodynamic performance of these new valves with conventional bioprosthetic valves are lacking.
Methods
Model development
Multi-slice computed tomography reconstructions in patients with aortic stenosis were used to generate a 3D printed model of an aortic root.
Effective diameter of the aortic annulus was 21 mm, effective area was 3.38 cm2 and LVOT area was 3.01 cm2.
Valve Deployment
For measurement of haemodynamic parameters (EOA, TPG and LVOT geometry), Magna Ease valves were sutured to the model’s annulus, with and without the use of pledgets, and EDWARDS INTUITY valves were secured by balloon inflation. EDWARDS INTUITY
valves were further tested with frames expanded
to 22, 23, 24 and 25 mm.
Figure 1: EDWARDS INTUITY and Magna Ease valves in the aortic root model and cadaver heart
A: EDWARDS INTUITY valve in the model;
B: Magna Ease valve in the model without pledgets;
C: Magna Ease valve in the model, with pledgets;
D: Outflow view of the aortic root model; E: EDWARDS INTUITY valve in the cadaver heart;
F: Magna Ease valve without pledgets in the cadaver heart.
Reproduced from Ai L et al, 2017. © 2017 Wolters Kluwer Health, Inc. Reproduced with permission LVOT in the rubber gasket aortic root model and in the cadaver heart.
Results
Hemodynamic Performance
The EDWARDS INTUITY valve had both a greater EOA and a lower TPG than the Magna Ease valve, irrespective of pledget use (Figure 1). EOA
and TPG were also significantly different between Magna Ease valves with and without pledgets (all p<0.002 or 0.001).
LVOT Performance
Expanding the EDWARDS INTUITY valve frame diameter from 22 to 25 mm increased the average LVOT area index stepwise from 1.07 to 1.34: this minimally affected EOA or TPG (Table 1).
EDWARDS INTUITY valves resulted in more circular LVOTs than Magna Ease valves, although increasing ellipticity did not impact EOA or TPG.
Average maximum flow velocity was lower across the EDWARDS INTUITY valve than the Magna Ease valve without pledgets (p<0.003), as were maximum turbulent shear stress (p<0.02) and turbulent kinetic
energy (p<0.002).
| EDWARDS INTUITY valve (n=4) | Magna Ease valve (n=4) | Magna Ease valve with pledgets (n=4) | |
| EOA, cm2 | 1.85 ± 0.06 | 1.56 ± 0.01 | 1.21 ± 0.08 |
| Mean gradient, mmHg | 16.8 ± 1.3 | 23.4 ± 0.51 | 1.21 ± 0.08 |
EOA: effective orifice area
Table 1: TPG and EOA of models with an EDWARDS INTUITY valve or a Magna Ease valve (with or without pledgets)
Limitations
- Such a model, isolated from the left ventricle, cannot replicate all physiological mechanical properties.
- Pathological changes and normal physiological variations can affect valve performance in vivo: these were not modelled here.
- The use of saline, rather than blood or a substitute, may have affected simulated valve performance.
Conclusions
- Haemodynamic performance was superior for the EDWARDS INTUITY valve than the Magna Ease valve with increased EOA and reduced mean gradient.
- Pledgets worsened Magna Ease valve performance.
- Maximum velocity, turbulent shear stress and kinetic energy were all lower across the EDWARDS INTUITY valve than the Magna Ease valve.
- Haemodynamic advantages may account for the superior clinical performance of rapid deployment valves over conventional surgical valves
Important safety information:
Use of the EDWARDS INTUITY Elite valve system may be associated with new or worsened conduction disturbances,
which may require a permanent cardiac pacemaker implant (PPI). The rate of PPI for the EDWARDS INTUITY Elite
valve is within the range reported in the literature for various rapid deployment valves, but higher than that reported
for surgical aortic valves. Physicians should assess the benefits and risks of the EDWARDS INTUITY Elite valve prior to
implantation. See instructions for use for additional information.
For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).
Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, EDWARDS INTUITY, EDWARDS INTUITY Elite, Magna, Magna Ease, PERI, PERIMOUNT and PERIMOUNT Magna are trademarks are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
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Rodríguez-Caulo, Emiliano A., et al., Journal of Thoracic and Cardiovascular Surgery (2021) DOI:10.1016/j.jtcvs.2021.01.118
Aim
Evaluate long-term survival and major adverse events in patients aged 50 to 65 years with a primary isolated AVR, with a bioprosthesis or mechanical valve, because of severe AS
Methods
- National observational study with all consecutive patients aged 50-65 who underwent AVR because of severe isolated AS between 2000 and 2018 in 27 hospitals in Spain
- In total, 5215 patients were included in the study (21% were bioprostheses)
- Among bioprostheses, 46.8% were Carpentier-Edwards, 19.4% Mitroflow, 4.2% Mosaic and 4.1% Trifecta
- 2:1 propensity matching analysis (1822 Mech and 911 Bio) with a mean follow-up of 8.1 years
Results
- In the matched cohort, long-term survival differences were not observed (cf. figure)
- Overall survival after Mech valves at 5, 10, 15 and 18 years of follow-up were 91%, 83%, 73% and 62% vs. 89%, 81%, 74% and 72% for bioprostheses, respectively
- Minor differences in survival were found in patients aged 50-55 years (P = 0.11)
- No significant differences in the composite of stroke, bleeding and reintervention (P = 0.484)
- Major bleeding (P = 0.002) and strokes (P = 0.095) had a higher frequency in the Mech valve group
- Rates of reoperation were significantly higher in the bioprosthesis valve group (P < 0.001)
- In a 1:1 propensity matching, the risk of reintervention in the Bio group decreased for patients who underwent AVR between 2009 and 2018 compared with 2000 to 2008
Conclusions
- Bioprostheses seem a reasonable choice for patients aged 50 to 65 years in Spain, particularly for those older than 55 years, because of the long-term survival and the lower-risk related, especially, to major bleeding compared with mechanical prostheses
- However, the higher risk of reoperation with bioprostheses should be considered and discussed with the patient to make the best-informed decision
Key talking points
Are these outcomes aligned with guideline recommendations? – Current ESC/EACTS guidelines consider mechanical and bioprosthetic valves as reasonable in patients aged 60 to 65 years, whereas AHA/ACC guidelines consider both reasonable in 50 to 65 y.o. patients. Therefore, findings from this national observational study with patients that underwent isolated AVR seem to be more aligned with the latest American guidelines.
Why did the risk of reintervention decrease in patients who underwent Bio AVR between 2009 and 2018? – The authors point to improved outcomes after AVR for both mech and bio prostheses after 2009. In the unadjusted cohort, there was a significant decrease in stroke, major bleeding and reintervention. In the bio group, the rate of reoperation because of SVD diminished from 7.6% to 4% after 2009, which is related to the durability of bioprostheses. Improvements in the bio group may be linked to the incorporation of newer anticalcification properties.
What is the mortality risk associated with prosthesis reintervention? – Today, mortality risk associated with prosthesis reintervention has been minimized, and most recent bioprostheses allow for “valve-in-valve” procedures for patients at high surgical risk.
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